WASHINGTON, (Reuters) – U.S. regulators approved a once-daily HIV pill by Gilead Sciences Inc, giving a new source of revenue to the leading maker of HIV medicines as it faces expiring patents.
The U.S. Food and Drug Administration on Wednesday gave a nod to the pill Complera for patients who have not received prior treatment for the virus that causes AIDS. The $1,705-a-month drug combines Gilead’s Truvada with Johnson & Johnson’s Edurant, which received FDA approval in May.
Gilead currently sells another once-daily pill, Atripla, that combines Truvada with Bristol-Myers Squibb Co’s Sustiva, but the California drugmaker earns no profit from the Bristol drug and all of the Atripla components lose patent protection in the next few years.
Under the deal with J&J, Gilead would keep up to 30 percent of what it will make off the Edurant component in Complera.